- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03361904
Colonoscopic Adenoma and Advanced Neoplasia Detection Rates According to Age
Adenoma and Advanced Neoplasia Detection Rates Increase From 45 Year of Age: Results of a Monocentric One-year Observational Cohort Study on 6027 Colonoscopies
Current recommendations for colonoscopy screening programs usually involve patients older than 50 years of age. However, little is known about polyp or adenoma detection rates under 50. We compared these detection rates according to age in a large series of patients in common practice.
Methods: All colonoscopies performed in 2016 in our unit were prospectively recorded. We determined adenoma detection rate (ADR), polyp detection rate (PDR), mean number of polyps (MNP), and advanced neoplasia detection rate (ANDR).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients All consecutive patients who were scheduled for colonoscopy were included. Exclusion criteria were: patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).
Data collection The following data have been prospectively collected: age, gender, indication for colonoscopy, preparation procedure and quality of the preparation (assessed by the Boston Bowel Preparation Scale; BBPS) [19-20], caecal intubation (yes/no), withdrawal time, number and size of polyps and polyp histopathology.
All clinical data were collected during the procedure by a nurse and an endoscopist on a dedicated software. The database was then supplemented by the Clinical Research Associate for histopathological data.
We determined adenoma detection rate (ADR; percentage of colonoscopies with at least one adenoma), polyp detection rate (PDR: percentage of colonoscopies with at least one polyp), mean number of polyps per colonoscopy (MNP), large polyp detection rate (LPDR; percentage of colonoscopies with at least one polyp of 1 cm or more) and advanced neoplasia detection rate (ANDR: percentage of colonoscopies with at least one advanced neoplastic lesion as defined below).
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All consecutive patients who were scheduled for colonoscopy were included.
Exclusion Criteria:
- patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adenoma detection rate according to age
Time Frame: during colonoscopy
|
ADR <30yo, in 30-34 yo, in 35-39yo, in 40-44yo, in 45-49yo, in 50-54yo, in 55-59yo, in 60-64yo, in 65-69 yo, in 70-74yo, in 75-79yo and >79yo intervals
|
during colonoscopy
|
|
Advanced Neoplasia Detection rate according to age
Time Frame: during colonoscopy
|
ANDR <30yo, in 30-34 yo, in 35-39yo, in 40-44yo, in 45-49yo, in 50-54yo, in 55-59yo, in 60-64yo, in 65-69 yo, in 70-74yo, in 75-79yo and >79yo intervals
|
during colonoscopy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: during colonoscopy
|
years old
|
during colonoscopy
|
|
Gender
Time Frame: during colonoscopy
|
Male or Female
|
during colonoscopy
|
|
Indication for colonoscopy
Time Frame: during colonoscopy
|
pain / screening/ familial or personal history of polyp or cancer
|
during colonoscopy
|
|
quality of the preparation
Time Frame: during colonoscopy
|
Boston Bowel Preparation Scale Segment Score Description 0: unprepared colon segment with mucosa not senn due to solid stool that cannot be cleared
Total score is a summation of scores from three segments of the colon Score is from 0 to 9 |
during colonoscopy
|
|
Caecal intubation
Time Frame: during colonoscopy
|
Y/N
|
during colonoscopy
|
|
Withdrawal time
Time Frame: during colonoscopy
|
in seconds
|
during colonoscopy
|
Collaborators and Investigators
Investigators
- Principal Investigator: David Karsenti, MD, Pole Digestif Paris-Bercy
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-ADR according to age
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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